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Alefacept in Patients With Severe Scalp Alopecia Areata

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ClinicalTrials.gov Identifier: NCT00167102
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : April 9, 2013
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Other
Condition Alopecia Areata
Intervention Drug: Alefacept
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description Weekly IM administration of alefacept,15 mg, for 12 weeks, followed by a 12-week, posttreatment observation period. Weekly IM administration of placebo, for 12 weeks, followed by a 12-week, posttreatment observation period.
Period Title: Overall Study
Started 23 22
Completed 23 22
Not Completed 0 0
Arm/Group Title Alefacept Placebo Total
Hide Arm/Group Description Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks. Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 23 22 45
Hide Baseline Analysis Population Description
23 participants were allocated to alefacept 22 participants were allocated to placebo
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
22
 100.0%
45
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 45 participants
38.3  (10.3) 34.2  (11.8) 36.3  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
Female
18
  78.3%
14
  63.6%
32
  71.1%
Male
5
  21.7%
8
  36.4%
13
  28.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 22 participants 45 participants
23 22 45
1.Primary Outcome
Title The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values
Hide Description Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept followed by a 12 week observation period in subjects with chronic severe scalp alopecia
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:
Weekly intramuscular administration of alefacept 15mg for 12 weeks
Weekly intramuscular administration of placebo 15 mg for 12 weeks
Overall Number of Participants Analyzed 23 22
Measure Type: Number
Unit of Measure: percentage of participants
8.7 13.6
2.Primary Outcome
Title Number of Adverse Events
Hide Description Number of any adverse event reported throughout the study, regardless of relation to study drug
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description:
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
Overall Number of Participants Analyzed 23 22
Measure Type: Number
Unit of Measure: adverse events
20 20
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alefacept Placebo
Hide Arm/Group Description Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks. Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
All-Cause Mortality
Alefacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alefacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/23 (4.35%)   2/22 (9.09%) 
Gastrointestinal disorders     
vomiting and dehydration * 1  0/23 (0.00%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
right elbow arthropathy * 1  1/23 (4.35%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma exacerbation * 1  0/23 (0.00%)  1/22 (4.55%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alefacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   20/23 (86.96%)   9/22 (40.91%) 
Gastrointestinal disorders     
Nausea * 1  2/23 (8.70%)  1/22 (4.55%) 
General disorders     
Headaches * 1  4/23 (17.39%)  3/22 (13.64%) 
Infections and infestations     
Infection * 1  4/23 (17.39%)  3/22 (13.64%) 
Cold * 1  4/23 (17.39%)  2/22 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Congestion * 1  8/23 (34.78%)  2/22 (9.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA
This study was limited by the number of patients randomized to receive treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Maria Hordinsky
Organization: University of Minnesota
Phone: 612-624-5721
EMail: hordi001@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00167102     History of Changes
Other Study ID Numbers: 0506M70377
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: February 27, 2013
Results First Posted: April 9, 2013
Last Update Posted: May 22, 2019